Rates of Middle Meatus Synechiae Formation Post ESS

NCT03036735 | Terminated Results

• 1 other identifier: 00723
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).

  Steroid eluting spacer will be measured by incidence of 35 and 90-day post Functional Endoscopic Sinus Surgery (FESS) incidence of middle meatal synechiae.

  35 to 90days

Study Arms (1)

Steroid Eluting Spacer

EXPERIMENTAL

Subjects will receive one steroid eluting spacer (Restora Mometasone Furate Eluting Spacer) placed into the surgical site on one side, and one spacer without drug (Silastic spacer) placed on the other side. The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

Device: steroid eluting spacer

Interventions

steroid eluting spacer DEVICE

The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.

Steroid Eluting Spacer

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 and 75 years
• Diagnosis of chronic rhinosinusitis (CRS), per current guidelines
• Patients who need to undergo primary bilateral complete endoscopic sinus surgery
• Subject has the ability to follow the study instructions, is willing to be available on the specific required study visit days, and is willing to complete all study visit procedures and assessments
• Subject must understand the research nature of this study and sign an informed consent prior to the performance of any study-specific procedure or assessment

You may not qualify if:

• Subject is pregnant or breast feeding
• Patients with sino-nasal tumors
• Patients solely undergoing nasal septal reconstruction
• Patients with previous history of endoscopic sinus surgery
• Cystic fibrosis or syndromic patients
• Patients with autoimmune diseases
• Patients who have taken oral steroids less than 30 days prior to surgery
• Patients with a history or diagnosis of glaucoma or ocular hypertension
• Any other circumstance or condition that in the Investigator's opinion causes the subject to be an inappropriate candidate for participating in this study

Sponsors & Collaborators

• Steward St. Elizabeth's Medical Center of Boston, Inc.: lead
• SinuSys Corporation: collaborator

MeSH Terms

Conditions

Sinusitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Dr Peter Catalano
• Organization: Steward Health Care

peter.catalano@steward.org

617-789-5004

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: At the end of surgery, the Surgery Fellow will insert either the Drug Eluting Spacer or the Silastic spacer into each side of the subject's nose. The subject will receive one of each spacer. The fellow will record which spacer was placed on which side using a special coding system to keep this information private. This maintains the blinding for the primary surgeon/outcome assessor and subject.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director otolaryngology

Model Details: Subjects undergoing endoscopic sinus surgery (ESS) will receive one steroid eluting spacer placed into the surgical site on one side, and one spacer without steroid placed on the other side.

Study Record Dates

• First Submitted: May 4, 2015
• First Posted: January 30, 2017
• Study Start: April 5, 2015
• Primary Completion: April 5, 2016
• Study Completion: December 1, 2016
• Last Updated: October 19, 2018
• Results First Posted: October 19, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will share